Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED)
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|ClinicalTrials.gov Identifier: NCT02945462|
Recruitment Status : Completed
First Posted : October 26, 2016
Last Update Posted : November 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Erectile Dysfunction||Biological: autologous mesenchymal stem cells||Phase 1|
Four diabetic male patients ranging from 25-65 years diagnosed with erectile dysfunction will be selected. This diagnosis is based on medical history, validated questionnaires, physical examinations, laboratory tests and specific diagnostic tests. Patients with any evidence of untreated hypogonadism, current urinary tract or bladder infection, clinically evident penile anatomical deformities, previous penile implant or penile vascular surgery, uncontrolled hypertension or hypotension, reported unstable Cardiovascular diseases, uncontrolled diabetes (HbA1c > 10%), or primary hyperlipidemia will be excluded. The investigators hypothesize that the intracavernous injection of stem cells will facilitate the recovery of erectile function resulting in satisfying clinical outcomes in patients.
This study was performed:
- To test the safety of autologous intracavernous bone marrow mesenchymal stem cells.
- To evaluate benefit for the patient concerning recovery of natural erection by performing detailed and specific diagnostic tests prior and post MSCs injection by a team from Jordan University Hospital and Cell Therapy Center in Jordan University.
- To study the feasibility, indication criteria and application modalities of Bone marrow mesenchymal stem cells for further wider study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Safety and Efficacy of Using Bone Marrow-derived Mesenchymal Stem Cells in the Treatment of Erectile Dysfunction in Diabetic Patients|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||October 2016|
Experimental: autologous mesenchymal stem cells
Autologous bone marrow derived stem cells will be injected twice intracavernously to enrolled erectile dysfunction patients
Biological: autologous mesenchymal stem cells
Patients will be injected with autologous mesenchymal stem cells, intracavernously
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: six months ]Observation of any relevant adverse side effect resulting from the injection. Assessing the safety of autologous Mesenchymal Stem Cells injection
- Assessment the efficacy of intracavernous injection measured by SHIM/IIEF/EHS questionnaire [ Time Frame: 18 months ]
Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells by Sexual Health Inventory for Men/ International Index for Erectile Function/ Erection Hardness Score (SHIM/IIEF/EHS) questionnaire.
For every patient tests would be performed at baseline and repeated at 1,3, 6,12, and 18 months post-injection.
- Evaluation the efficacy of intracavernous injection measured by Dynamic Infusion cavernosometry test. [ Time Frame: 6 months ]Assessing the therapeutic benefits of the injected Autologous Mesenchymal Stem Cells by Dynamic Infusion Cavernosometry test at baseline and repeated at 6 months post injection.